PurposeNondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus.MethodsPatients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments.ResultsNo significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results.ConclusionThe radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities.

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Biodegradable magnesium-based implants are currently being developed for use in orthopedic applications. The aim of this study was to investigate the acute, subacute, and chronic local effects on bone tissue as well as the systemic reactions to a magnesium-based (MgYREZr-alloy) screw containing rare earth elements. The upper part of the screw was implanted into the marrow cavity of the left femora of 15 adult rabbits (New Zealand White), and animals were euthanized 1 week, 12 weeks, and 52 weeks postoperatively. Blood samples were analyzed at set times, and radiographic examinations were performed to evaluate gas formation. There were no significant increased changes in blood values compared to normal levels. Histological examination revealed moderate bone formation with direct implant contact without a fibrous capsule. Histopathological evaluation of lung, liver, intestine, kidneys, pancreas, and spleen tissue samples showed no abnormalities. In summary, our data indicate that these magnesium-based screws containing rare earth elements have good biocompatibility and osteoconductivity without acute, subacute, or chronic toxicity.

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This is the first larger study analyzing the use of magnesium-based screws for fixation of modified Chevron osteotomies in hallux valgus surgery. Forty-four patients (45 feet) were included in this prospective study. A modified Chevron osteotomy was performed on every patient and a magnesium screw used for fixation. The mean clinical follow up was 21.4 weeks. The mean age of the patients was 45.5 years. Forty patients could be provided with the implant, in four patients the surgeon decided to change to a standard metallic implant. The AOFAS, FAAM and pain NRS-scale improved markedly. The hallux valgus angle, intermetatarsal angle and sesamoid position improved significantly. Seven patients showed dorsal subluxation, rotation or medial shifting of the metatarsal heads within the first 3 months. One of these patients was revised, in all others the findings were considered clinically not significant or the patients refused revision. This study shows the feasibility of using magnesium screws in hallux valgus-surgery. Surgeons starting with the use of these implants should be aware of the proper handling of these implants and should know about corrosion effects during healing and its radiographic appearance. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:2207-2214, 2016.

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The first degradable implant made of a magnesium alloy, a compression screw, was launched to the clinical market in March 2013. Many different complex considerations are required for the marketing authorization of degradable implant materials. This review gives an overview of existing and proposed standards for implant testing for marketing approval. Furthermore, different common in vitro and in vivo testing methods are discussed. In some cases, animal tests are inevitable to investigate the biological safety of a novel medical material. The choice of an appropriate animal model is as important as subsequent histological examination. Furthermore, this review focuses on the results of various mechanical tests to investigate the stability of implants for temporary use. All the above aspects are examined in the context of development and testing of magnesium-based biomaterials and their progress them from bench to bedside. A brief history of the first market launch of a magnesium-based degradable implant is given. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 329-347, 2017.